Materials and methods for producing blood products

Abstract

Provided herein are materials and methods for the preparation of blood products. In one aspect, provided herein is a composition including platelets or platelet derivatives and an aqueous medium, wherein the aqueous medium has a protein concentration less than 50% of the protein concentration of donor apheresis plasma.

What is claimed is: 
     
         1 . A process for preparing a composition comprising platelets or platelet derivatives and an aqueous medium, the process comprising:
 tangential flow filtration (TFF) of a starting material comprising platelets, a diluted starting material comprising platelets, a concentrated platelet composition, or a combination thereof, thereby preparing a composition comprising platelets or platelet derivatives and aqueous medium,   wherein the aqueous medium has a protein concentration less than or equal to 50% of the protein concentration of donor apheresis plasma.   
     
     
         2 . The process of  claim 1 , further comprising a pathogen reduction step. 
     
     
         3 . The process of  claim 1 , wherein the starting material has a protein concentration of about 60 to about 80 mg/mL. 
     
     
         4 . The process of  claim 1 , wherein TFF comprises diafiltering with a preparation agent comprising a buffering agent comprising HEPES (4-(2-hydroxyethyl)-1-piperazineethanesulfonic acid), a base comprising sodium bicarbonate, and a loading agent comprising trehalose, polysucrose, or a combination thereof. 
     
     
         5 . The process of  claim 1 , wherein the preparation agent comprises an organic solvent comprising ethanol, DMSO, or a combination thereof. 
     
     
         6 . The process of  claim 1 , wherein the protein concentration of the aqueous medium is less than or equal to 10% of the protein concentration of donor apheresis plasma. 
     
     
         7 . The process of  claim 1 , wherein the protein concentration of the aqueous medium is about 7% to about 10% of the protein concentration of donor apheresis plasma. 
     
     
         8 . The process of  claim 1 , wherein the composition comprises less than 5.0% (by scattering intensity) microparticles. 
     
     
         9 . The process of  claim 1 , further comprising lyophilizing and/or cryopreserving the composition comprising platelets or platelet derivatives. 
     
     
         10 . The process of  claim 1 , further comprising thermally treating the composition comprising platelets or platelet derivatives. 
     
     
         11 . The process of  claim 1 , wherein the platelets or platelet derivatives have a CD41 percent positivity of at least 55%. 
     
     
         12 . The process of  claim 1 , wherein the platelets or platelet derivatives have a CD42 percent positivity of at least 80%. 
     
     
         13 . The process of  claim 1 , wherein the platelets or platelet derivatives have an annexin V percent positivity of at least 70%. 
     
     
         14 . The process of  claim 1 , wherein the platelets or platelet derivatives have CD47 percent positivity of at least 8%. 
     
     
         15 . The process of  claim 1 , wherein the platelets or platelet derivatives have CD62 percent positivity of at least 80%. 
     
     
         16 . The process of  claim 1 , wherein the platelets or platelet derivatives have fibrinogen associated with the cell membrane. 
     
     
         17 . The process of  claim 1 , wherein the platelets or platelet derivatives, when at a concentration of about 4.8×10 3  particles/μL generate a thrombin peak height (TPH) of at least 25 nM when in the presence of a reagent containing tissue factor and phospholipids. 
     
     
         18 . The process of  claim 1 , wherein the platelets or platelet derivatives, when at a concentration of at least about 70×10 3  particles/μL, produce an occlusion time of less than 14 minutes in a total thrombus-formation analysis system (T-TAS) assay. 
     
     
         19 . The process of  claim 1 , wherein the platelets or platelet derivatives have a potency of at least 1.5 thrombin generation potency units (TGPU) per 10 6  particles. 
     
     
         20 . The process of  claim 1 , wherein the platelet derivatives comprise thrombosomes. 
     
     
         21 . The process of  claim 1 , wherein the composition is:
 a) negative for HLA Class I antibodies based on a regulatory agency approved test;   b) negative for HLA Class II antibodies based on a regulatory agency approved test;   c) negative for HNA antibodies based on a regulatory agency approved test; or   d) one or more of a), b), and c).   
     
     
         22 . A composition comprising platelets or platelet derivatives and an aqueous medium, wherein the aqueous medium has a protein concentration less than or equal to 50% of the protein concentration of donor apheresis plasma.